Quality
IPAX is Committed to Quality.
Manufacturing is performed in controlled environments. We have a 4,000 sq. ft. Cleanroom maintained and certified to the ISO 14644 Class 7 standard. Attention to detail is demonstrated by our manufacturing staff. We source product components worldwide to provide the best solution to your custom device needs.
We provide expertise and support to our customers on E-Beam, Gamma, Ethylene Oxide and Moist Heat Sterilization methods. Our knowledgeable staff assists customers daily with process and product validation activities. We also provide assistance and information for any customer-specific requirement on a per-shipment basis. We always assist customers with labeling development and supply.
As a customer, you will find our Manufacturing and Quality Assurance Departments to be indispensible in meeting all customer and regulatory requirements.
If you require a Medical device to be sold within the United States:
We are an FDA registered facility and we follow U.S. Food & Drug Administration Good Manufacturing Practices (GMP) for medical applications. We are audited routinely by regulatory agencies and welcome and accommodate all levels of customer audits.


